Job Description
Product Development Engineer
Addivation Medical
Headquartered in Chester, New Jersey, Addivation Medical aims to accelerate medical devices innovation using metal 3D printing and nanotechnology.
Job Summary
As a Product Development Engineer, you will work on a cross-functional team with Quality, Manufacturing, Regulatory, and Marketing to successfully launch and maintain orthopedic and spine medical devices. You will be responsible for the design and development of new implants and instruments.
Responsibilities
- Design medical implants and instruments from concept to market launch. Responsibilities will cover all aspects of the process from prototyping to commercial release.
- Understand customer needs through research, partnerships with marketing, and direct interactions with the customer.
- Evaluate prototypes via bench testing, surgeon feedback, manufacturability assessments, and inspection requirements in accordance with Design Control processes.
- Creation of test protocols/reports, design review reports, risk management reports, and other supporting documents to comply with the design control processes.
- Support regulatory and quality requirements in compliance to ISO 13485:2016 and FDA regulations.
- Create, update, and maintain design control process work instructions.
- Work in a collaborative environment, interacting with cross-functional teams (Product & Project Management, Manufacturing, Quality/Regulatory, Operations, and Marketing).
Requirements
- B.S. in engineering and 2+ years related experience. Experience in orthopedics is highly desired; spine experience is also a plus.
- Must have a passion for medical devices and customer satisfaction.
- Expertise in CAD modeling (SolidWorks preferred), mechanical design, and creation of engineering drawings including GD&T.
- Must understand manufacturing processes including 3D printing, machining, surface treatment, cleaning, packaging, and sterilization.
- Experience with statistical analysis software is a plus.
- Must demonstrate strong written and verbal skills with experience presenting technical information in a small group setting.
- Must work well in a small team and fast-paced environment.
- Must have a demonstrated ability to communicate effectively and work well with co-workers and customers.
- Be a proactive person who attacks problems, displaying initiative and perseverance to bring about meaningful change, and to be open and responsive to new ideas.
- Be known as a person who has high integrity, sound character, a tremendous work ethic and the passion to succeed.
Job Type: Full-time
Location: New Jersey
